BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2210780 · Received August 12, 2011

    Report

    Report Number
    2649622-2011-13604
    Event Type
    Death
    Date Received
    August 12, 2011
    Date of Event
    July 29, 2009
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    Z-0475-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE(S) ASSOCIATED WITH THIS ADVERSE OUTCOME WAS/WERE REPORTED WHEN IDENTIFIED IN THE MANUFACTURE DATABASE. THE PATIENT DIED TWO YEARS AGO. CONSEQUENTLY, CONTACT INFORMATION TO COMPLETE FOLLOW-UP IS NOT REASONABLY KNOWN. THEREFORE, ATTEMPTS FOR ADDITIONAL INFORMATION CANNOT BE MADE. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    INFORMATION IDENTIFIED IN THE MANUFACTURE'S DATA BASE INDICATED THE PATIENT DIED APPROXIMATELY NINE MONTHS POST THE IMPLANT OF AN IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) TWO YEARS AGO. CAUSE OF DEATH IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT QUATTRO SECURE IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death